NotinKansas ... Very interesting breakdown (optimized group versus undertreated group).
Thanks for your great initiative. It's well appreciated.
NotinKansas - (9/10/2022 1:14:52 PM)
The optimized cohort in the latest report
If one deducts from the results reported in the MD&A of 30 August (a) the results reported for the 12 undertreated patients (which can be derived from the MD&A of 28 April 2022) and (b) the results for the three fully dosed patient from Phase 1b, one is left with the latest results for only the optimized patients treated in Phase 2. I have just done exactly that and then calculated the response rates for both the undertreated and optimized cohorts, using the respective evaluable patients totals for each assessment milestone. Below is the result. There may be a margin of error given the company’s ever changing and not always transparent way of reporting the data, but if there is, I would expect it to be small. What’s clear is the tendency for the optimized cohort to (increasingly) convincingly outperform the undertreated cohort. Only at 450 days are we still lacking confirmation, but the next update (end of November?) should take care of that. I’m admittedly biased, but with the optimized cohort, we’re actually not that far from reproducing the Phase 1b results. And was that not what the FDA was hoping to see? GLTA & DYOR
| | Complete Response | Partial Response | Total Response | No Response |
| Days | U | O | U | O | U | O | U | O |
| 90 | 33% | 57% | 17% | 17% | 50% | 74% | 50% | 26% |
| 180 | 30% | 52% | 20% | 33% | 50% | 86% | 50% | 14% |
| 270 | 30% | 42% | 10% | 32% | 40% | 74% | 60% | 26% |
| 360 | 20% | 38% | 10% | 15% | 30% | 54% | 70% | 46% |
| 450 | 20% | 9% | 10% | 18% | 30% | 27% | 70% | 73% |
| U = Undertreated | O = Optimized | |